1. Field of the Invention
This invention relates to an at least partially implantable hearing system for rehabilitation of a hearing disorder comprising at least one acoustic sensor for picking up an acoustic signal and converting the acoustic signal into corresponding electrical audio sensor signals, an electronic signal processing unit for audio signal processing and amplification, an electrical power supply unit which supplies individual components of the system with energy, and at least one electromechanical output transducer which has an electrical input impedance and which, when implanted, is coupled via a coupling element to at least one of a middle ear and an inner ear for mechanical stimulation thereof
2. Description of Related Art
The expression xe2x80x9chearing disorderxe2x80x9d is defined here as including an inner ear damage, a combined inner ear and middle ear damage, and a temporary or permanent noise impression (tinnitus).
Electronic measures for rehabilitation of inner ear damage which cannot be cured by surgery have currently achieved great importance. With total failure of the inner ear, cochlear implants with direct electrical stimulation of the remaining auditory nerves are in routine clinical use. For medium to severe inner ear damage, for the first time, fully digital hearing devices are presently being used which open up a new world of electronic audio signal processing and offer expanded possibilities of controlled audiological fine tuning of the hearing devices to the individual inner ear damage. In spite of major improvements of hearing aid hardware achieved in recent years, in conventional hearing aids, there remain basic defects which are caused by the principle of acoustic amplification, i.e. especially by the reconversion of the electronically amplified signals in airborne sound. These defects include aspects such as the visibility of the hearing aids, poor sound quality as a result of electromagnetic transducers (speakers), closed external auditory canal as well as feedback effects at high acoustic gain.
As a result of these fundamental defects, there has long been the desire to move away from conventional hearing aids with acoustic stimulation of the damaged inner ear and to replace them by partially or fully implantable hearing systems with direct mechanical stimulation. Implantable hearing systems differ from conventional hearing aids: the acoustic signal is converted with a proper microphone into an electrical signal and amplified in an electronic signal processing stage; this amplified electrical signal, however, is not sent to an electroacoustical transducer (speaker), but to an implanted electromechanical transducer providing for output-side mechanical vibrations which are sent directly, therefore with direct mechanical contact, to the middle ear or inner ear, or indirectly via an air gap in, for example, electromagnetic converter systems. This principle applies regardless of whether implantation of all necessary system elements is partial or complete and also regardless of whether an individual with pure inner ear impairment with a completely intact middle ear or an individual with combined hearing impairment, in which the middle and inner ear is damaged, is to be rehabilitated. Therefore implantable electromechanical transducers and methods for coupling the mechanical transducer vibrations to the functioning middle ear or directly to the inner ear for rehabilitation of a pure inner ear impairment, or to a remaining ossicle of the middle ear in the case of an artificially or pathologically altered middle ear for taking care of a hearing disorder caused by a disturbance of sound conduction, or for combinations of such disorders, have been described in the recent scientific literature and in many patents.
Useful electromechanical transducer processes include basically all physical transducer principles, such as electromagnetic, electrodynamic, magnetostrictive, dielectric and piezoelectric. Various research groups, in recent years, have focused essentially on two of these processes, namely electromagnetic and piezoelectric processes. A survey can be found in H. P. ZENNER and H. LEYSIEFFER (HNO 10/1997, vol. 45, pp. 749-774).
In the piezoelectric process, direct mechanical coupling of the output-side transducer vibrations to the middle ear ossicle or to the oval window is essential. In the electromagnetic principle, force coupling between the transducer and ossicle, on the one hand, can take place xe2x80x9cwithout contactxe2x80x9d, i.e. via an air gap; in this case, only the permanent magnet is caused to vibrate by the transducer being in direct mechanical contact with the middle ear ossicle by permanent fixation. On the other hand, it is possible to implement the transducer entirely in a housing (in this case the coil and the magnet preferably being coupled with the smallest possible air gap) and to transmit the output-side vibrations via a mechanically stiff coupling element with direct contact to the middle ear ossicle (see FREDRICKSON et al.: Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss; Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121; and H. Leysieffer et al., HNO 10/97, vol. 45, pp. 792-800).
The patent literature contains some of the aforementioned versions of both electromagnetic and also piezoelectric hearing aid transducers: U.S. Pat. No. 3,712,962, EPLEY; U.S. Pat. No. 3,870,832, FREDRICKSON; U.S. Pat. No. 3,882,285, NUNLEY et al.; U.S. Pat. No. 4,850,962, SCHAEFER; U.S. Pat. No. 5,015,224, MANIGLIA; U.S. Pat. No. 5,277,694, LEYSIEFFER et al.; U.S. Pat. No. 5,554,096, BALL; U.S. Pat. No. 5,707,338, ADAMS et al.; U.S. Pat. No. 6,123,660, LEYSIEFFER; U.S. Pat. No. 6,162,169, LEYSIEFFER; International Patent Application Publications WO-A 98/06235, ADAMS et al.; WO-A 98/06238, ADAMS et al.; WO-A 98/06236, KROLL et al.; WO-A 98/06237, BUSHEK et al.
The partially implantable piezoelectric hearing system of the Japanese group of Suzuki and Yanigahara presupposes, for implantation of the transducer, the absence of the middle ear ossicles and a free tympanic cavity to be able to couple the piezo element to the stapes (Yanigahara et al.: Efficacy of the partially implantable middle ear implant in middle and inner ear disorders: Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 149-159; Suzuki et al.: Implantation of partially implantable middle ear implant and the indication. Adv. Audiol., Vol. 4, Karger Basel (1988), pp. 160-166). Likewise, in the method of implanting a hearing system for inner ear hearing-impaired according to SCHAEFER (U.S. Pat. No. 4,850,962) basically the incus is removed in order to be able to couple a piezoelectric transducer element to the stapes. This also applies to further developments which are based on the SCHAEFER technology and which are described in the above mentioned patents (U.S. Pat. No. 5,707,338, ADAMS et al.; International Patent Application Publications WO-A 98/06235, ADAMS et al.; WO-A 98/06238, ADAMS et al.; WO-A 98/06236, KROLL et al.; WO-A 98/06237, BUSHEK et al.).
The BALL electromagnetic transducer (xe2x80x9cFloating Mass Transducer FMTxe2x80x9d of U.S. Pat. No. 5,554,096, BALL; U.S. Pat. No. 5,624,376, BALL et al.) is, on the other hand, directly fixed to the long process of the incus when the middle ear is intact. The electromagnetic transducer of the partially implantable system of FREDRICKSON (Fredrickson et al.: Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121) is directly mechanically coupled to the body of the body of the incus when the ossicular chain of the middle ear is likewise intact. The same applies to the piezoelectric transducers of LEYSIEFFER (LEYSIEFFER et al.: An implantable piezoelectric hearing aid converter for the inner ear hearing-impaired. HNO 1997/45, pp. 792-800; U.S. Pat. No. 5,277,694, LEYSIEFFER et al.; U.S. Pat. No. 6,123,660, LEYSIEFFER; U.S. Pat. No. 6,162,169, LEYSIEFFER). Also in the electromagnetic transducer system of MANIGLIA (MANIGLIA et al.: Contactless semi-implantable electromagnetic middle ear device for the treatment of sensorineural hearing loss, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 121-141) with the ossicular chain intact a permanent magnet is permanently mechanically fixed to the ossicular chain, but is mechanically driven via an air gap coupling by a coil.
In the described transducer and coupling versions, basically, two implantation principles can be distinguished:
a) In the case of the one principle the electromechanical transducer with its active transducer element is located itself in the middle ear region in the tympanic cavity and the transducer is directly connected there to an ossicle or to the inner ear (U.S. Pat. Nos. 4,850,962, 5,015,225, 5,707,338, 5,624,376, 5,554,096, and International Patent Application publication Nos. WO 98/06235, WO 98/06238, WO 98/06236, and WO 98/06237).
b) In the other principle the electromagnetic transducer with its active transducer element is located outside of the middle ear region in an artificially formed mastoid cavity; the output-side mechanical vibrations are then transmitted to the middle or inner ear by means of mechanically passive coupling elements via suitable surgical accesses (the natural aditus ad antrum, opening of the chorda-facialis angle or via an artificial hole from the mastoid) (Fredrickson et al.: Ongoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing loss. Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121; U.S. Pat. No. 5,277,694; U.S. Pat. No. 6,123,660; U.S. Pat. No. 6,162,169).
An advantage of the a) type versions is, that the transducer can be made as a so-called xe2x80x9cfloating massxe2x80x9d transducer, i.e., the transducer element does not require any xe2x80x9creactionxe2x80x9d via secure screwing to the skull bone, but it vibrates based on the laws of mass inertia with its transducer housing and transmits these vibrations directly to a middle ear ossicle (U.S. Pat. Nos. 5,624,376, 5,554,096, and 5,707,338, and International Patent Application publication no. WO 98/06236). On the one hand, this means that an implantable fixation system on the cranial vault can be advantageously omitted; on the other hand, this version disadvantageously means that bulky artificial elements must be placed in the tympanic cavity, and their long-term stability and biostability are currently not known or guaranteed, especially in the case of temporary pathological changes of the middle ear (for example, otitis media). Another major disadvantage is that the transducer together with its electrical supply line has to be transferred from the mastoid into the middle ear and must be fixed there using suitable surgical tools; this requires an expanded access through the chorda facialis angle, and thus, entails a latent hazard to the facial nerve which is located in the immediate vicinity. Furthermore, such xe2x80x9cfloating massxe2x80x9d transducers can be used merely in a very limited manner or not at all, when the inner ear is to be directly stimulated for example via the oval window, or when, due to pathological changes, for example the incus is substantially damaged or is no longer present, so that such a transducer no longer can be mechanically connected to an ossicle that is able to vibrate and is in connection with the inner ear.
A certain disadvantage of the transducer versions as per b) is that the transducer housing is to be attached to the cranial vault with the aid of implantable positioning and fixation systems (advantageous embodiment U.S. Pat. No. 5,788,711). A further disadvantage of the transducer versions as per b) is that a recess is to be made, preferably by an appropriate laser, in the respective ossicle in order to allow the application of the coupling element. This, on the one hand, is technically complicated and expensive and, on the other hand, involves risks for the patient. Both in the partially implantable system of FREDRICKSON (xe2x80x9cOngoing investigations into an implantable electromagnetic hearing aid for moderate to severe sensorineural hearing lossxe2x80x9d, Otolaryngologic Clinics of North America, Vol. 28/1 (1995), pp. 107-121) as well as in the fully implantable hearing system of LEYSIEFFER and ZENNER (HNO 1998, vol. 46, 853-863 and 844-852), when the vibrating transducer part is coupled to the body of the incus, it is assumed that for permanent and mechanically secure vibration transmission the tip of the coupling rod which is placed in the laser-induced depression of the middle ear ossicle undergoes osseointegration over the long term, i.e., the coupling rod coalesces solidly with the ossicle and thus ensures reliable transmission of dynamic compressive and tensile forces. However, this long-term effect is currently not yet scientifically proven or certain. Furthermore, in this type of coupling, in case of a technical transducer defect, there is the disadvantage that decoupling from the ossicle to remove the transducer can only be done with mechanically based surgical methods; this can mean considerable hazard to the middle ear and especially the inner ear. Therefore further coupling elements, partly involving novel surgical access paths, were developed which minimize or no longer have the above mentioned disadvantages (U.S. Pat. No. 5,941,814, LEHNER et al., commonly owned U.S. patent applications Ser. Nos. 09/576,009; 09/613,560; 09/626,745; 09/680,489).
The major advantage of these converter embodiments as per b), however, is that the middle ear remains largely free and coupling access to the middle ear can take place without major possible hazard to the facial nerve. One preferable surgical process for this purpose is described in U.S. Pat. No. 6,077,215, LEYSIEFFER.
In view of the described various modes of access and coupling techniques numerous coupling elements for transmitting in an effective and long-term stable manner the mechanical vibratory energy of the transducers to the coupling site of the middle ear or inner ear were developed and described. Also implantable hearing systems were described which use, for stimulation of the damaged hearing, not only a single transducer but rather a plurality of electromechanical transducers to provide for an optimum stimulation of the multi-channel cochlear amplifier and thus to attain a better rehabilitation of the damaged hearing than when utilizing a single transducer only. Advantageous embodiments of such coupling elements and transducer arrangements are described in more detail below.
The coupling quality of the mechanical excitation is influenced by many parameters and contributes significantly to rehabilitation of hearing loss and to the perceived hearing quality. Intraoperatively, this quality of coupling can only be assessed with difficulty or not at all, since the amplitudes of motion of the vibrating parts even at the highest stimulation levels are in a range around or far below 1 xcexcm, and therefore, they cannot be assessed by direct visual inspection. Even as this is done using other technical measurement methods, for example, by intraoperative laser measurements (for example, laser doppler vibrometry), the uncertainty of a long-term stable, reliable coupling remains, since this can be adversely affected among others by necroses formation, tissue regeneration, air pressure changes and other external and internal actions. In particular, in completely implantable systems, it remains necessary to be able to assess the coupling quality of the transducer, since in a full implant, it is not possible to separately measure individual system components at their technical interfaces if, for example, the implant wearer complains of inferior transmission quality which cannot be improved by reprogramming of individual audiological adaptation parameters, and therefore, surgical intervention to improve the situation cannot be precluded. Even if this is not the case, there is fundamental scientific interest in having available a reliable monitor function of long term development of the quality of the transducer coupling.
International Patent Application Publication WO-A 98/36711 proposes a process utilizing objective hearing testing methods, such as ERA (electric response audiometry), ABR (auditory brainstem response) or electro-cochleography, in the case of fully and partially implantable systems with mechanical or electrical stimulation of the damaged or failing hearing. Stimuli responses evoked by application of proper stimuli are objectively detected by electrical extraction via external head electrodes or implanted electrodes. This method has the advantage that objective data for the transmission quality can be determined during a surgical procedure under general anesthesia. The essential disadvantages, however, amongst others, are that these objective hearing testing methods can be of qualitative nature only, essentially provide for data at the auditory threshold only and not or only to a limited extent above this threshold, and particularly are of insufficient accuracy in the case of frequency-specific measurements. A subjective valuation of the transmission quality and subjective audiological measurements in the region above the auditory threshold, such as loudness scalings, are not possible.
It has been proposed (commonly owned copending U.S. patent application Ser. No. 09/369,180) to circumvent the indicated disadvantages by determining the quality of coupling of the electromechanical transducer to the middle or inner ear, respectively, by psychoacoustical measurements, i.e. by subjective patient replies, without further biological-technical interfaces which may impair the determination of the transducer coupling quality being included in the valuation. For this purpose an audiometer is integrated into a fully implantable hearing system or into the implantable part of a partially implantable hearing system. This audiometer consists of one or more electronic signal generators which can by set or programmed from the outside and which feed an electrical hearing test signal into the signal processing path of the implant. Thereby, the electromechanical output transducer of the implanted hearing system is directly electrically controlled in a technically reproducible and quantitatively predetermined manner, so that corruption of the stimulation level, as can occur for example by presenting the audiometrical test sounds by headphones or particularly acoustic free field presentation, is avoided because the sensor or microphone function together with all associated variability is incorporated into the psychoacoustical measurement.
This procedure, amongst others, has the advantage that e.g. frequency-specific measurements of the auditory threshold using pure sinusoidal tones or narrow-band signals (for example, third octave noise) can be very easily reproduced even at longer study time intervals. Furthermore, the procedure also permits the acquisition of reproducible psychoacoustical data in the region above the auditory threshold, such as loudness scalings. In addition, by offering pure signals, such as, for example, sinusoidal signals, nonlinearities which can arise, for example, by diminishing coupling quality and which can be perceived as nonlinear distortions, may also be subjectively interrogated. Such studies are possible to only a limited extent or not at all by the above described objective measurement methods based upon evoked potentials.
All the discussed methods for examining the coupling quality of the electromechanical transducer or transducers are disadvantageous in that either a subjective valuation of the patient influences the result or that physiological interfaces are included in the measurement. Both aspects lead to unreliable measuring results and hence do not represent an optimum solution, particularly with respect to reproduced
A primary object of the present invention is to devise an at least partially implantable hearing system which permits in a particularly reliable manner an objective measurement of the coupling quality even during operation.
This object is achieved in that, in an at least partially implantable hearing system for rehabilitation of a hearing disorder comprises at least one acoustic sensor for picking up an acoustic signal and converting the acoustic signal into corresponding electrical audio sensor signals, an electronic signal processing unit for audio signal processing and amplification, an electrical power supply unit which supplies individual components of the system with energy, at least one electromechanical output transducer for mechanical stimulation of the middle and/or inner ear, and means for objectively determining the quality of coupling between the at least one output transducer and at least one of the middle ear and the inner ear, said determining means comprising impedance measuring means for measuring the mechanical impedance of a biological load structure which, upon implantation of the output transducer, is coupled to the output transducer.
The solution of the subject invention has the particular advantage that the coupling quality of the output transducer or output transducers can be intraoperatively judged and, if necessary, intraoperatively improved immediately upon coupling of the transducer to the biological hearing structure before the implantation is terminated without having exact knowledge about the success of the coupling since normally the patient is operated under general anesthesia so that psychoacoustical measurements are not possible.
A further advantage of the subject invention is that the coupling quality of the output transducer or output transducers can be postoperatively monitored on a long-time base without the necessity of subjecting the patient to any particular procedure. For this purpose the software surface used by the audiologist or the hearing aid acoustician to adapt the implant to the individual impaired hearing, for example, includes a module for triggering an implant-side impedance measurement either automatically on occasion of software initialization or by an active request, with the respective data being telemetrically transmitted to the software surface for further evaluation and judgement.
Furthermore, in conformity with the invention, such impedance measurements may be triggered and carried out by the implant itself, without an active measuring command, at predetermined time intervals or upon the occurrence of a predetermined operational state of the implant, with respective impedance measurement results being stored as digital data in a respective storage area of the implant at least until retrieval of the impedance measurement results from the outside.
The impedance measuring means may comprise means for measuring the electrical input impedance of the electromechanical output transducer or transducers coupled to the biological load structure. The magnitude and phase data of this electrical input impedance reflect the load components coupled to the transducer or transducers because these are transformed to the electrical side by the electromechanical coupling of the transducer or transducers, and thus can be measured.
Preferably, the or each electromechanical output transducer is driven by a driver unit to which the respective output transducer is connected via a measuring resistance, and a measuring amplifier is provided which has applied thereto as input signals the transducer terminal voltage and a measuring voltage which is dropped across the measuring resistance and is proportional to the transducer current. In order to preclude a corruption of the measurements, the voltage drop across the measuring resistance preferably is taken off in a floating and high impedance manner, and the measuring resistance advantageously is dimensioned such that the sum of the resistance value of the measuring resistance and of the absolute value of the complex electrical input impedance of the electromechanical output transducer coupled to the biological load structure is large with respect to the internal resistance of the driver unit. Furthermore, preferably digital, means are provided for forming the quotient of the transducer terminal voltage and the transducer current.
According to an alternate embodiment of the invention the impedance measuring means, however, also may be designed for direct measurement of the mechanical impedance of the biological load structure coupled, upon implantation of the output transducer, to the electromechanical output transducer, and such impedance measuring means may be integrated into the output transducer at an actoric output side thereof. Preferably, the impedance measuring means is designed for generating measuring signals which are at least approximately proportional as to magnitude and phase to either the force acting on the biological load structure or the velocity of the coupling element. In such a case, the system advantageously further includes a two-channel measuring amplifier with multiplexer function and, preferably digital, means for providing the quotient of the measuring signal corresponding to the force acting on the biological load structure and of the measuring signal corresponding to the velocity of the coupling element.
In the case of the direct impedance measurement the electromechanical output transducer and the impedance measuring means may be disposed within a common housing which optionally also receives the measuring amplifier.
The described impedance measurements by no means are restricted to a single measuring frequency or to a single measuring level. Rather, advantageously for indirect as well as for direct measurement of the mechanical impedance of the biological load structure, preferably digital, means are provided for measuring the mechanical impedance of the biological load structure coupled, upon implantation of the output transducer, to the electromechanical output transducer as a function of the frequency and/or of the level of the stimulation signal delivered by the output transducer. Measurements extending over the entire transmission frequency range and the entire stimulation level range of the respective hearing implant are particularly suited to gain, during the postoperative monitoring phase, important detailed information about linear and particularly non-linear variations of the quality of the coupling of the electromechanical output transducer or transducers to the biological load structure. Thus, for example, it may be expected that a mechanical non-linearity of the coupling to a middle ear ossicle (xe2x80x9cdistortionxe2x80x9d) that may negatively influence the transmitted sound quality, can be detected by varying the electrical level during the impedance measurement.
In conformity with a further embodiment of the invention, preferably digital, means may be provided for detecting the spectral distribution of resonance frequencies in the course of the mechanical impedance measured as a function of the frequency of the stimulation signal, and also means for detecting the difference between values of the mechanical impedance occurring at the resonance frequencies. This difference gives information as to the mechanical oscillation Q.
The above described approach basically may be utilized in connection with all known transducer principles, such as in the case of electromagnetic, electrodynamic, magnetostrictive, dielectric and particularly piezoelectric transducers. Accordingly, in the system design of the hearing implant there are basically no restrictions as to the type of transducers, and in a multi-channel actor design also mixed types of transducer principals may be provided for in order to attain an optimum stimulation of the hearing.
The electromechanical output transducer, in the implanted state, may be mechanically connected to the biological load structure via a passive coupling element and/or a coupling rod, and the impedance measuring means may be incorporated into the coupling rod.
Preferably, the electronic signal processing unit is designed to also process the signals of the impedance measuring means. Advantageously, the signal processing unit comprises a digital signal processor which provides for processing of the signals of the impedance measuring means as well as for processing the audio sensor signals and/or for generation of digital signals for tinnitus masking. In order to provide for the respective actual measurement of the electrical transducer impedance, the signal processor may shortly interrupt the audio signal of the hearing system to supply the respective measuring signals which, for example, are generated by the signal processor itself
In case no level analysis as to non-linearities of the transducer coupling over the entire range of useful levels is provided for, the measurement of the electrical transducer impedance also may be carried out below the auditory threshold in quiet of the respective patient in order to avoid disturbance of the patient by the measuring signals. For this purpose, the respective patient""s data relating to the auditory threshold in quiet may be stored in a storage area of the system, and the measuring software of the signal processor then may refer to such data.
The signal processor can be designed to be static such that as a result of scientific findings respective software modules are filed once in a program storage of the signal processor and remain unchanged. But then if later, for example due to more recent scientific findings, improved algorithms for signal processing are available and these improved algorithms are to be used, the entire implant or implant module which contains the corresponding signal processing unit must be replaced by a new unit comprising the altered operating software by invasive surgery on the patient. This surgery entails renewed medical risks for the patient and is very complex.
This problem can be solved in that, in another embodiment of the invention, a rewritable implantable storage arrangement is assigned to the signal processor for storage and retrieval of an operating program, and at least parts of the operating program are adapted to be at least partially replaced or changed by data transmitted from an external unit via a telemetry means. In this way, after implantation of the implantable system, the operating software as such, inclusive of software for controlling the above described impedance measuring means, can be changed or completely replaced, as is explained for otherwise known systems for rehabilitation of hearing disorders in U.S. Pat. No. 6,198,971.
Preferably, the design is such that, in addition, for fully implantable systems, in the known manner, operating parameters, i.e., patient-specific data, for example, audiological adaptation data, or variable implant system parameters (for example, as a variable in a software program for controlling the impedance measuring means or for control of battery recharging) can be transmitted transcutaneously into the implant after implantation, i.e., wirelessly through the closed skin, and thus, can be changed. Here, preferably, the software modules are designed to be dynamic or re-programmable to provide for an optimum rehabilitation of the respective hearing disorder. In particular, the software modules can be designed to be adaptive, and parameter matching can be done by training by the implant wearer and optionally by using other aids.
Furthermore, the signal processing electronics can contain a software module which achieves stimulation as optimum as possible based on an adaptive neural network. Training of this neural network can take place again by the implant wearer and/or using other external aids.
The storage arrangement for storage of operating parameters and the storage arrangement for storage and retrieval of the operating program can be implemented as storages independent of one another; however there can also be a single storage in which both the operating parameters and also operating programs can be filed.
The subject approach allows matching of the system to circumstances which can be detected only after implantation of the implantable system. Thus, for example, in an at least partially implantable hearing system for rehabilitation of a monaural or binaural inner ear disorder and of a tinnitus by mechanical stimulation of the inner ear, the sensoric (acoustic sensor or microphone) and actoric (output stimulator) biological interfaces are always dependent on anatomic, biological and neurophysiological circumstances, for example on the interindividual healing process. These interface parameters can also be individual, especially time-variant. Thus, for example the transmission behavior of an implanted microphone can vary interindividually and individually as a result of being covered by tissue, and the transmission behavior of an electromechanical transducer which is coupled to the inner ear can vary interindividually and individually in view of different coupling qualities. These differences of interface parameters, which cannot be eliminated or reduced in the devices known from the prior art even by replacing the implant, now can be optimized by changing or improving the signal processing of the implant.
In an at least partially implantable hearing system, it can be advisable or become necessary to implement signal processing algorithms which have been improved after implantation. Especially the following should be mentioned here:
speech analysis processes (for example, optimization of a fast Fourier transform (FFT)),
static or adaptive noise detection processes,
static or adaptive noise suppression processes,
processes for optimization of the signal to noise ratio within the system,
optimized signal processing strategies in progressive hearing disorder,
output level-limiting processes for protection of the patient in case of implant malfunctions or external faulty programming,
processes of preprocessing of several sensor (microphone) signals, especially for binaural positioning of the sensors,
processes for binaural processing of two or more sensor signals in binaural sensor positioning, for example optimization of spacial hearing or spacial orientation,
phase or group delay time optimization in binaural signal processing,
processes for optimized driving of the output stimulators, especially in the case of binaural positioning of the stimulators.
Among others, the following signal processing algorithms can be implemented with this system even after implantation:
processes for feedback suppression or reduction,
processes for optimization of the operating behavior of the output transducer(s) (for example, optimization of the frequency response and phase response, improvement of the impulse response),
speech signal compression processes for sensorineural hearing loss,
signal processing methods for recruitment compensation in sensorineural hearing loss.
Furthermore, in implant systems with a secondary power supply unit, i.e., a rechargeable battery system, but also in systems with primary battery supply it can be assumed that these electrical power storage units will enable longer and longer service lives and thus increasing residence times in the patients as technology advances. It can be assumed that fundamental and applied research for signal processing algorithms will make rapid progress. The necessity or the patent desire for operating software adaptation and modification will therefore presumably take place before the service life of the implanted power source expires. The system described here allows this adaptation of the operating programs of the implant even when the implant has already been implanted.
Preferably, there can furthermore be provided a buffer storage arrangement in which data transmitted from the external unit via the telemetry means can be buffered before being relayed to the signal processor. In this way the transmission process from the external unit to the implanted system can be terminated before the data transmitted via the telemetry means are relayed to the signal processor.
Furthermore, there can be provided checking logic which checks the data stored in the buffer storage arrangement before relaying the data to the signal processor. There can be provided a microprocessor module, especially a microcontroller, for control of the signal processor within the implant via a data bus, preferably the checking logic and the buffer storage arrangement being implemented in the microprocessor module, wherein also program parts or entire software modules can be transferred via the data bus and the telemetry means between the outside world, the microprocessor module and the signal processor.
An implantable storage arrangement for storing a working program for the microprocessor module is preferably assigned to the microprocessor module, and at least parts of the working program for the microprocessor module can be changed or replaced by data transmitted from the external unit via the telemetry means.
In another embodiment of the invention, at least two storage areas for storage and retrieval of at least the operating program of the signal processor may be provided. This contributes to the reliability of the system, in that due to the multiple presence of a storage area which contains the operating program(s), for example, after transmission from the exterior or when the implant is turned on, checking for the absence of faults in the software can be done.
Analogously to the above, the buffer storage arrangement can also comprise at least two storage areas for storage and retrieval of data transferred from the external unit via the telemetry means, so that after data transmission from the external unit still in the area of the buffer storage the absence of errors in the transferred data can be checked. The storage areas can be designed for example for complementary filing of the data transferred from the external unit. At least one of the storage areas of the buffer storage arrangement, however, can also be designed to store only part of the data transferred from the external unit, wherein in this case the absence of errors in the transferred data is checked in sections.
Furthermore, to ensure that in case of transmission errors, a new transmission process can be started, a preprogrammed read-only memory area which cannot be overwritten can be assigned to the signal processor, in which ROM area the instructions and parameters necessary for xe2x80x9cminimum operationxe2x80x9d of the system are stored, for example, instructions which after a xe2x80x9csystem crashxe2x80x9d ensure at least error-free operation of the telemetry means for receiving an operating program and instructions for its storage in the control logic.
As already mentioned, the telemetry means is advantageously designed not only for reception of operating programs from the external unit but also for transfer of operating parameters between the implantable part of the system and the external unit such that on the one hand such parameters (for example the volume) can be adjusted by a physician, a hearing aid acoustics specialist or the wearer of the system himself, and on the other hand the system can also transfer the parameters to the external unit, for example to check the status of the system.
A totally implantable hearing system of the aforementioned type can have on the implant side in addition to the actoric stimulation arrangement and the signal processing unit at least one implantable acoustic sensor and a rechargeable electrical storage element, and in this case a wireless transcutaneous charging device can be provided for charging of the storage element. For a power supply there can also be provided a primary cell or another power supply unit which does not require transcutaneous recharging. This applies especially when it is considered that in the near future, mainly by continuing development of processor technology, a major reduction in power consumption for electronic signal processing can be expected so that for implantable hearing systems new forms of power supply will become usable in practice, for example power supply which uses the Seebeck effect, as is described in U.S. Pat. No. 6,131,581. Preferably, there is also provided a wireless remote control for control of the implant functions by the implant wearer.
In case of a partially implantable hearing system, at least one acoustic sensor, an electronic signal processing arrangement, a power supply unit and a modulator/transmitter unit are contained in an external module which can be worn outside on the body, especially on the head over the implant. The implant comprises the output-side electromechanical transducer and the impedance measuring means, but is passive in terms of energy and receives its operating energy and transducer control data via the modulator/transmitter unit in the external module.
The described system can be designed to be monaural or binaural for the fully implantable design as well as for the partially implantable design. A binaural system for rehabilitation of a hearing disorder of both ears has two system units which each are assigned to one of the two ears. In doing so the two system units can be essentially identical to one another. However, one of the system units can also be designed as a master unit and the other system unit as a slave unit which is controlled by the master unit. The signal processing modules of the two system units can communicate with one another in any way, especially via a wired implantable line connection or via a wireless connection, preferably a bidirectional high frequency path, a ultrasonic path coupled by bone conduction, or a data transmission path which uses the electrical conductivity of the tissue of the implant wearer such that in both system units optimized binaural signal processing and transducer array control are achieved.
These and further objects, features and advantages of the present invention will become apparent from the following description when taken in connection with the accompanying drawings which, for purposes of illustration only, shows several embodiments in accordance with the present invention.